Air particle counter equipment qualification (IQ and OQ)

Quality Assurance
1

is it acceptable if IQ/OQ is performed by the third party without been witnessed by the user?

2

IQ/OQ can be performed by the third party but in the presence of the user.

1 Like
3

In my experience you can purchase a written PQ from the manufacturer. Combined with other appropriate documents, it will serve as a validation package for the equipment which is needed to validate the EM program for the facility.

4

What is EM program?

5

Environmental Monitoring

1 Like
6

It can be acceptable if you have given authorization to the third party to conduct IQ/OQ on your behalf.

7

Dear ,

Provided the Service provider should have trained staffs,certification or accredited, audited and approved facility, use of calibrated and validated standards, follow GMP Norms.
Thanks

1 Like